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    Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Merck & Cie

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    01 Bisoprolol Fumarate (2)

    02 Calcium (1)

    03 Calcium Folinate (1)

    04 Dotap Chloride (1)

    05 Levoleucovorin Calcium (1)

    06 Loratadine (1)

    07 Mesalazine (1)

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    01 Active (4)

    02 Inactive (1)

    03 Blank (3)

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    01 Valid (2)

    02 Withdrawn by Holder (1)

    03 Blank (5)

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    01 217MF11012 (1)

    02 217MF11281 (1)

    03 218MF10352 (1)

    04 220MF10126 (1)

    05 Blank (4)

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    01 Blank (8)

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    Calcium Folinate

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    USDMF

    Found USDMF

    5261
    Active
    CALCIUM FOLINATE (CALCIUM LEUCOVORI...
    1984-01-23
    CEP/COS

    Found CEP/COS

    R1-CEP 1996-055 - Rev 08
    Valid
    Calcium folinate hydrate
    2023-05-19
    Japanese DMF

    Found JDMF

    218MF10352
    Calcium folinate at Weisshausmatte ...
    2006-03-17
    Written Confirmation

    Close WC

    Application Number
    5261
    R1-CEP 1996-055 - Rev 08
    218MF10352
    Status
    Active
    Fees Paid
    Reviewed
    Valid
     
    Filing Details
    CALCIUM FOLINATE (CALCIUM LEUCOVORI...
    Calcium folinate hydrate
    Calcium folinate at Weisshausmatte ...
    Issue/Submission Date
    1984-01-23
    2023-05-19
    2006-03-17
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    Levoleucovorin Calcium

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    USDMF

    Found USDMF

    20327
    Active
    CALCIUM LEVOFOLINATE PENTAHYDRATE
    2007-02-28
    CEP/COS

    Found CEP/COS

    R1-CEP 2001-266 - Rev 06
    Valid
    Calcium levofolinate hydrate
    2023-05-19
    Japanese DMF

    Found JDMF

    217MF11281
    Levofolinate calcium at Weisshausma...
    2005-12-20
    Written Confirmation

    Close WC

    Application Number
    20327
    R1-CEP 2001-266 - Rev 06
    217MF11281
    Status
    Active
    Fees Paid
    N/A
    Valid
     
    Filing Details
    CALCIUM LEVOFOLINATE PENTAHYDRATE
    Calcium levofolinate hydrate
    Levofolinate calcium at Weisshausma...
    Issue/Submission Date
    2007-02-28
    2023-05-19
    2005-12-20
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    Bisoprolol Fumarate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    217MF11012
    Bisoprolol fumarate at WEISSHAUSMAT...
    2005-11-21
    Written Confirmation

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    Application Number
    217MF11012
    Status
     
    Filing Details
    Bisoprolol fumarate at WEISSHAUSMAT...
    Issue/Submission Date
    2005-11-21
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    Bisoprolol Fumarate

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    USDMF

    Close USDMF

    CEP/COS

    Close CEP/COS

    Japanese DMF

    Found JDMF

    220MF10126
    Bisoprolol fumarate at WEISSHAUSMAT...
    2008-05-15
    Written Confirmation

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    Application Number
    220MF10126
    Status
     
    Filing Details
    Bisoprolol fumarate at WEISSHAUSMAT...
    Issue/Submission Date
    2008-05-15
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    Calcium

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    USDMF

    Found USDMF

    20040
    Active
    L-METHYLFOLATE CALCIUM
    2006-12-12
    CEP/COS

    Close CEP/COS

    Japanese DMF

    Close JDMF

    Written Confirmation

    Close WC

    Application Number
    20040
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    L-METHYLFOLATE CALCIUM
    Issue/Submission Date
    2006-12-12
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    Loratadine

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    USDMF

    Found USDMF

    6626
    Active
    LORATADINE
    1986-10-15
    CEP/COS

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    Japanese DMF

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    Written Confirmation

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    Application Number
    6626
    Status
    Active
    Fees Paid
    N/A
     
    Filing Details
    LORATADINE
    Issue/Submission Date
    1986-10-15
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    Dotap Chloride

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    USDMF

    Caution USDMF

    26513
    Inactive
    (R)-DOTAP CHLORIDE
    2012-09-28
    CEP/COS

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    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    26513
    Status
    Inactive
    Fees Paid
    N/A
     
    Filing Details
    (R)-DOTAP CHLORIDE
    Issue/Submission Date
    2012-09-28
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    Mesalazine

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    USDMF

    Close USDMF

    CEP/COS

    Caution CEP/COS

    R1-CEP 2004-254 - Rev 01
    Withdrawn by Holder
    Mesalazine, Micronised
    2013-01-31
    Japanese DMF

    Close JDMF

    Written Confirmation

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    Application Number
    R1-CEP 2004-254 - Rev 01
    Status
    Withdrawn by Holder
     
    Filing Details
    Mesalazine, Micronised
    Issue/Submission Date
    2013-01-31
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